UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063584 |
|---|---|
| Receipt number | R000072761 |
| Scientific Title | Effectiveness of web-based intervention for life-change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: A randomized controlled trial |
| Date of disclosure of the study information | 2026/11/11 |
| Last modified on | 2026/11/10 17:44:03 |
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Basic information
Public title
Effectiveness of web-based intervention for life-change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: A randomized controlled trial
Acronym
Effectiveness of web-based intervention for life-change adaptation in family caregivers of individuals with acquired brain injury
Scientific Title
Effectiveness of web-based intervention for life-change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: A randomized controlled trial
Scientific Title:Acronym
Effectiveness of web-based intervention for life-change adaptation in family caregivers of individuals with acquired brain injury
Region
| Japan |
Condition
Condition
family caregivers of community-dwelling individuals with acquired brain injury
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of this research is to examine the effectiveness of a web-based intervention known as the Koji-fam.net 3-day program (KF3 PGM) for life-change adaptation of family caregivers of community-dwelling individuals with ABI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The life change adaptation scale(LCAS) Japanese version (Shindo & Tadaka, 2020)
Key secondary outcomes
The Multidimensional Scale of Perceived Social Support (MSPSS)(Iwasa et al., 2007)
The Positive Appraisal of Care scale (PAC)(Yamamoto-Mitani et al., 2001; Yamamoto et al., 2002)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants in the intervention group will access a program consisting of ecomapping and a message board (an anonymous online communication system) via a dedicated website for 5-15 minutes per day over three consecutive days.
Interventions/Control_2
Participants in the waitlist control group will continue their usual daily activities and will be provided with information about the program after completing the final survey.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Providing care for a family member or relative.
2. Having a primary care recipient under their care who has been diagnosed with higher brain dysfunction.
3. Being able to respond in Japanese in an environment with access to the Internet.
Key exclusion criteria
1. Unable to provide informed consent to participate in the study.
2. Younger than 18 years of age.
3. Having missing data on the Life Change Adaptation Scale at baseline.
4. Failing the attention check in the baseline survey.
5. Deemed ineligible to participate in the study by the internet survey panel provider
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Iwata |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Community and Public Health Nursing
Zip code
060-0812
Address
K12-N5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-3377
iwata.yuk@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Iwata |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Community and Public Health Nursing
Zip code
060-0812
Address
K12-N5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-3377
Homepage URL
iwata.yuk@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Iwata Yuka
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University
Address
K12-N5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-3377
iwata.yuk@pop.med.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 10 | Day |
Last modified on
| 2026 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072761
